FDA WARNING_LETTER - TENTAMUS INDIA PRIVATE LIMITED - August 22, 2025

The FDA issued a Warning Letter to Tentamus India Private Limited following an inspection from August 14 to 22, 2025. The letter identifies significant violations of Current Good Manufacturing Practice (CGMP) regulations, resulting in the classification of tested drug products as adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations include the quality control unit"s failure to ensure CGMP compliance and data integrity, evidenced by discarded analytical records and the use of unofficial personal diaries. The company also failed to thoroughly investigate unexplained discrepancies, such as microbiological sample issues and unaddressed out-of-specification (OOS) results for a drug sample, where results were inexplicably changed without justification. Additionally, the firm did not contemporaneously document laboratory control mechanisms, with instances of pre-signed and backdated records observed. Furthermore, the inspection was hampered by the company delaying and limiting access to requested records.

Required actions include a comprehensive, third-party led investigation into data inaccuracies, a risk assessment of the impact on drug quality, and a detailed management strategy encompassing global corrective and preventive actions. The company must also establish a robust remediation plan for its Quality Unit, conduct a third-party assessment of method validations, and implement a thorough review and improvement of its OOS investigation systems. A complete assessment and remediation of documentation practices are also mandated to ensure accurate and contemporaneous record-keeping.